UMIN-CTR Clinical Trial

Basic information
Public title	Verification of training effect with a balance exercise assist robot in rehabilitation hospital target patients with femoral fracture
Acronym	Verification of training effect with a balance exercise assist robot target femoral fracture patients
Scientific Title	Verification of training effect with a balance exercise assist robot in rehabilitation hospital target patients with femoral fracture
Scientific Title:Acronym	Verification of training effect with a balance exercise assist robot target femoral fracture patients
Region	Japan

Condition
Condition	femoral fracture patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aim the verification of training effect with a balance exercise assist robot in rehabilitation hospital target patients with femoral fracture. The outcomes are gait, balance ability and falls experience in a year later.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BBS; Berg balance scale
Key secondary outcomes	BMI(Body Mass Index) muscle strength (grip, length) walking speed SIDE(Standing test for imbalance and disequilibrium) FRT(Functional Reach Test) TUG(Timed Up & Go Test)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	This study target patients with femoral fracture in rehabilitation hospital who can walk themselves under supervision. Interventions are training with a balance exercise assist robot in two weeks, twenty minutes per a day.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The general condition is stable Strong fixation of bone fracture such as osteosynthesis The walking FIM(functional independent measures)>=5 Informed-consent has been obtained
Key exclusion criteria	Conservative treatment for fracture part High-blood pressure(systolic blood pressure>=180 mmHg or diastolic blood pressure>=120 mmHg or resting heart rate>=120/min) Restricted by movement due to heart function or respiratory function disorder hearing or visual impairment Dementia or severe higher brain dysfunction
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Izumi Middle name Last name Kondo
Organization	National Center for Geriatrics and Gerontology
Division name	Rehabilitation Center
Zip code	474-8511
Address	7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL	0562-46-2311
Email	ik7710@ncgg.go.jp

Public contact
Name of contact person	1st name Izumi Middle name Last name Kondo
Organization	National Center for Geriatrics and Gerontology
Division name	Rehabilitation Center
Zip code	474-8511
Address	7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL	0562-46-2311
Homepage URL
Email	ik7710@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	TOYOTA MOTOR CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University
Address	65, Tsurumai, Showaku, Nagoya
Tel	052-744-2061
Email	nishida.kazuhiro@adm.nagoya-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立研究開発法人　国立長寿医療研究センター（愛知県）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 26 Day

Related information
URL releasing protocol	https://jrct.niph.go.jp/re/reports/detail/1356
Publication of results	Partially published

Result
URL related to results and publications	https://jrct.niph.go.jp/re/bulletins/detail/1180/4947
Number of participants that the trial has enrolled	49
Results	Data for 49 subjects (mean 80.5 years old) were compared before and after exercise by corresponding t test. As a result, the injury side ankle plantar flexor strength was 3.0kgf (p<0.05), the injured side knee extension strength was 1.3kgf (p<0.05), the injured side hip abductor strength was improved by 1.3kgf (p<0.05), BBS increased by 3.3 (p<0.01) and FRT increased by 2.3cm (p<0.05). Walking speed improved by 0.2 m/s (p<0.01) and TUG improved by -3.1 seconds (p<0.01).
Results date posted	2020 Year 02 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 07 Month 22 Day
Baseline Characteristics	The mean age of the 49 subjects was 80.5+-7.2 years, 18 males and 43 females.
Participant flow	Men and women aged 65 years or older who were hospitalized in the recovery period and who had undergone surgical procedures after sustaining a proximal femur fracture were recruited, and those who understood the study and gave consent were included.
Adverse events	none.
Outcome measures	Primary endpoint: Interviews by telephone to determine if there were any falls or fractures 1 year after the end of the intervention Secondary endpoints: - Medical record information: age, gender, current medical history, date of injury, height and weight - Motor function: gait independence (FIM; Functional Independent Measure), gait speed (10 m gait, TUG; Timed Up and Go test), balance ability (Berg Balance Scale (BBS), SIDE; Standing Gait speed (10 m walk, TUG; Timed Up and Go test) Balance ability (Berg Balance Scale (BBS), SIDE; Standing test for imbalance and disequilibrium) Muscle strength (hand-held dynamometer) (Muscle strength (lower limb muscle strength measurement using a hand-held dynamometer; hip abductor strength, knee extensor strength, ankle plantar flexor strength, grip strength) Fall anxiety (FES-I; Falls Efficacy Scale - International) Asking about whether pain worsens before and after practice
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 01 Day
Date of IRB	2019 Year 05 Month 31 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	As this study falls under the category of specific clinical research, we will continue to disclose information on the progress of the study on jRCT. https://jrct.niph.go.jp/re/reports/detail/1356

Management information
Registered date	2018 Year 06 Month 26 Day
Last modified on	2022 Year 09 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037804